MARK3

Basic Information

• Brand Name: MARK3
• Primary DI: D79611501
• Version / Model: 1150
• Catalog Number: 1150
• Company Name: CARGUS INTERNATIONAL, INC
• Labeler DUNS: 096191093
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2022-03-23
• Public Version: 3
• Public Version Date: 2023-09-20
• Public Version Status: Update
• Public Device Record Key: 659ed092-d9c6-41ab-a255-677bb60d3cd6

Device Description

eXact VPS 380 Impression Material Heavy Body Regular Set 2/pk. - MARK3®*

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ELW	Material, Impression	Dental	872.3660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35866	Silicone dental impression material	An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	D7961150	HIBCC
Primary	D79611501	HIBCC
Package	D79611502	HIBCC	Box	2	In Commercial Distribution
Package	D79611503	HIBCC	Case	100	Not in Commercial Distribution	2023-09-14
Package	D79611504	HIBCC	Case	12	Not in Commercial Distribution	2023-09-19
Package	D79611505	HIBCC	Case	12	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 50 – 77 Degrees Fahrenheit